Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MAMMOGRAPHIC S-RAY SYSTEM

K-Number: K833243 · 1983-10-28

ApplicantXerox Medical Systems
Decision Date1983-10-28
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAMMOGRAPHIC S-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Xerox Medical Systems. It received FDA 510(k) clearance on 1983-10-28 under 510(k) number K833243. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAMMOGRAPHIC S-RAY SYSTEM?

MAMMOGRAPHIC S-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 1983-10-28. The listed applicant is Xerox Medical Systems. The 510(k) number is K833243.

When did MAMMOGRAPHIC S-RAY SYSTEM receive FDA 510(k) clearance?

MAMMOGRAPHIC S-RAY SYSTEM received FDA 510(k) clearance on 1983-10-28, under 510(k) number K833243.

Who is the listed applicant for MAMMOGRAPHIC S-RAY SYSTEM?

The FDA 510(k) record lists Xerox Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAMMOGRAPHIC S-RAY SYSTEM?

The FDA product code for MAMMOGRAPHIC S-RAY SYSTEM is IZH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Xerox Medical Systems as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K853459XERORADIOGRAPHY LIQUID TONER IMAGING SYSTEMK832733XEROX 120 SYS MAMMOGRAPHIC X-RAYK812024XEROX 128 CASSETTE CHANGERK791014DENTAL XERORADIOGRAPHY

Related Devices (Code: IZH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K203509SMART FINDERIms Giotto S.P.A.K202294Affirm Contrast BiopsyHologic, Inc.K191495Biopsy PositionerFujifilm CorporationK161575Affirm Lateral Arm Upright Biopsy AccessoryHologicK161920Comfort CoverPrecision Dynamics CorporationK153486Affirm Prone Biopsy SystemHologic, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑